The European Medicines Agency (EMA) has recommended conditional approval for the vaccine from AstraZeneca and Oxford University in people aged 18 and over. The EMA announced on Friday. After the Biontech and Moderna vaccines, this is the third Covid-19 vaccine that the EMA has recommended for approval.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) had previously assessed the data on the quality, safety and efficacy of the vaccine and “recommended by consensus that the European Commission grant a formal conditional approval”. This assures EU citizens that the vaccine meets EU standards.
“With this third positive statement, we have further expanded the arsenal of vaccines available to EU and EEA member states to fight the pandemic and protect their citizens,” said Emer Cooke, EMA Executive Director. “As in previous cases, the CHMP has given this vaccine a rigorous assessment and the scientific basis of our work underscores our firm commitment to protecting the health of EU citizens.”
The permanent vaccination commission had only recommended vaccine for under 65-year-olds – EMA leaves this open
The vaccine from AstraZeneca can also be used in this country after approval by the EMA. However, the Standing Vaccination Commission (Stiko) recommended the vaccine from AstraZeneca and Oxford University in a draft only for under 65-year-olds, as it became known on Thursday.
Earlier, the head of the European approval authority (EMA) had surprised Emer Cooke by saying that she was not ruling out approval that was restricted to certain age groups. Insiders have been quietly reporting for days that the vaccine could only be approved for people up to 65 years of age. Officially, however, there was no information regarding an age limit.
However, the EMA said nothing to the discussion about a possible admission with age restriction. In her statement, she merely pointed out that most of the participants in the studies were between 18 and 55 years old, and that there were not yet enough results in older participants to indicate effectiveness for this group.
“Protection is expected, however, as an immune response is observed in this age group and based on experience with other vaccines; Since there is reliable information on safety in this population, the EMA’s scientific experts believe that the vaccine can be used in older adults. More information is expected from ongoing studies that include a higher proportion of older participants, ”the EMA said.
The approval process was accompanied by a dispute with the EU Commission
The approval process was overshadowed by an escalating dispute between AstraZeneca and the EU Commission. Instead of 80 million cans as agreed, the company only wants to deliver 30 million in the first quarter – a complete disaster for all EU countries. AstraZeneca explained in an unusual statement why it is not possible to send cans for the EU treaty from one of the other production sites.
“Each supply chain has been developed through the commitment and investment of specific countries or international organizations based on the supply agreements we have made. This enabled us to use local production wherever possible and reduce transport and potential export or import restrictions, which is ultimately intended to aid in the timely delivery of vaccines. Because each supply chain has been set up according to the requirements of the respective agreement, the vaccine produced by each supply chain is intended for the relevant markets or regions. “
AstraZeneca currently has at least 150 million vaccine doses in India alone in the first quarter
This is a unique process worldwide. As a rule, the production site does not play a role in the distribution of vaccines. The statement sounds like an excuse. Because AstraZeneca currently has at least 150 million vaccine doses in India alone in the first quarter.
India, the world’s largest vaccine manufacturer, could theoretically step into the breach with the EU. The Serum Institute of India is the largest vaccine production company in the world. The company has been producing the Oxford / AstraZeneca vaccine for months. It was only announced today in the India Times that the Serum Institute could deliver 150 million doses to its partners in the first quarter.
How exactly the global allocation of the rare commodity looks like remains open for the time being. In its last statement, AstraZeneca does not give an exact number for deliveries to the EU by the end of March. There is talk of several million doses in February and March. No vaccination plan can be designed with this nebulous statement.
No expert was able to confirm in the run-up to the EMA consultations whether this behavior of the pharmaceutical company is related to the rumors of an age restriction for EU approval. Because the question is: who will get the vaccine if it is only approved for people up to 65 years of age?
It has been known for months that almost no elderly people were examined when the studies began
Since October 1, 2020, the EMA has been checking the study data submitted by Oxford / AstraZeneca in a step-by-step process (rolling review). The European rapporteur for this vaccine is the German Paul Ehrlich Institute – the authority for the assessment of vaccines.
It has been known for months that Oxford University and AstraZeneca examined almost no elderly people when they began their studies. A publication in the journal “Lancet” in December shows that only four percent of the test subjects were over 70 years old.
Thus, at the moment no statement can be made about the effectiveness in older people. The EMA will have requested further data from the company, which were discussed in the course of the approval. Experts had assumed an age-restricted admission. The individual countries could then have decided individually whether they also wanted to release the vaccine for older people.
Who should receive an active ingredient that does not protect 38 out of 100 people?
The effectiveness of the vaccine was already the subject of controversial discussion in the professional world when Oxford University and AstraZeneca announced that their vaccine was 70 percent effective. In fact, the two full doses regime only worked a disappointing 62 percent. Half and full doses in an extremely small group of subjects were 90 percent effective.
Oxford / AstraZeneca has applied for approval from EMA for the administration of two full doses. Which group of people should receive an active ingredient that does not protect against Covid-19 in 38 out of 100 people? And that in view of the multiple infectious mutations?
When the confusing results on the effectiveness of the vaccine became known in December, the US FDA decided to wait for the data from a large US study to assess how the substance works in test subjects from all age groups. Experts expect the results of these studies in April or May of this year. Only then will there be a possible emergency approval in the USA.
There were also doubts about the safety of the vaccine
It is already becoming apparent that the Oxford / AstraZenca vaccine will probably not achieve the good efficacy data from Moderna and Biontech, which had demonstrated 95 percent effectiveness.
Still, the UK had rushed ahead and approved the serum in December. This was followed, for example, by India with its 300 million inhabitants.
There were also doubts about the safety of the vaccine. There were three cases of severe spinal cord inflammation in the clinical study. Only one case may have something to do with the vaccine, it said from company circles. A second case was attributed to the fact that the subject had multiple sclerosis, a serious nerve disease. One case occurred in the group that received the dummy drug.
Still, these cases resulted in the US and UK trials being halted in early September. In the USA even over a period of four weeks. It was already clear then that the development of this vaccine would be delayed. Because the safety of a new vaccine is paramount. The reason for the high safety standards is that healthy people and not seriously ill receive the serum.